09:28 AM EST, 01/21/2025 (MT Newswires) -- Amylyx Pharmaceuticals ( AMLX ) said Tuesday that the US Food and Drug Administration has lifted a clinical hold on a phase 1 clinical trial of AMX0114, an amyotrophic lateral sclerosis treatment candidate.

The company said it is now in the process of opening US sites for screening, enrollment and dosing with the lifting of the clinical hold.

Amylyx said the lifting of the clinical hold comes as it expects to start a phase 1 clinical trial in Canada that will assess the safety and biological activity of AMX0114, adding that it anticipates early group data from the study this year.

Shares were down 5.2% ahead of Tuesday's opening bell.